Method of Adjuvant Cancer Treatment

Abstract

The present invention provides a method of providing adjuvant treatment to a human patient which comprises administering to such a patient therapeutically effective doses of debrafenib and trametinib for a time period sufficient to increase relapse-free survival (RFS).

Description

BACKGROUND OF THE INVENTION[0001]This invention relates to a method of treating subjects after complete resection of cutaneous melanoma.[0002]Cutaneous melanoma is the most aggressive form of all skin cancers. Although it represents only 4% of all cancers, its incidence is continuing to rise in the world at a rate exceeding all other cancers (Jemal A, Siegel R, Ward E et al. Cancer statistics, 2007. CA Cancer J Clin 2007; 57: 43-66). Worldwide it is expected that approximately 132,000 people will be diagnosed with melanoma each year and approximately 37,000 people are expected to die of the disease annually (World Health Organization (WHO). Skin cancers. In Ultraviolet radiation and the INTERSUN Programme. Retrieved 7 Feb. 2012).[0003]Surgical resection is the treatment of choice for localized melanoma and frequently results in cures for early stage (I and II) disease, with a 90% long term (10-year) survival rate for stage I disease Balch et al., Final Version of 2009 AJCC Melanoma ...

AI Technical Summary

Benefits of technology

[0005]The present invention provides a method of providing adjuvant treatment to a patient with a prior diagnosis of melanoma which has been resected, which comprises administering to such a patient therapeutically effective doses of dabrafenib and trametinib for a time period sufficient to increase relapse-free survival (RFS).

[0006]According to one embodiment of the invention, there is provided a method of increasing relapse-free survival (RFS) after resection of melanoma, which comprises administration of a) dabrafenib and b) trametinib.

[0007]According to another embodiment of the invention, there is provided the combination of dabrafenib and trametinib for use in increasing relapse-free survival (RFS) after resection of melanoma.

Problems solved by technology

However, patients with lymph node involvement ≧1mm, including those detected only by sentinel lymph node biopsy, are at high risk of both local and distant relapse after definitive surgery due to the frequent presence of distant micrometastatic disease at presentation (Kirkwood et al.

Although significant progress has been made recently with new treatments for metastatic melanoma, therapeutic options in the adjuvant setting remain limited.

Although high-dose interferon is currently the only approved therapy for the adjuvant treatment of melanoma it is not widely accepted as the standard of care.

Increasing evidence surrounding a questionable survival benefit, a high incidence of serious toxicities, and negligible benefit for patients with bulkier disease makes it an unattractive therapy for most patients and clinicians (Schuchter, 2004).

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